Method of using a micro optical sensor device

ABSTRACT

A method of using a sensor device for measuring a concentration of a substance within a sample includes inserting a tip portion of a sensor into a sample. The sensor has an optical transmission member having a first end and a second end. The second end has the tip portion attached thereto and an active material incorporated within the tip portion. The active material is capable of interacting with a substance within the sample. The method includes producing a reflected beam of light from the interaction of the active material with the substance within the sample, the reflective beam of light having a second wavelength different from the first wavelength. The method includes determining the concentration of the substance based on the reflected beam of light.

CROSS-REFERENCE TO RELATED APPLICATIONS

This is a continuation-in-part of U.S. patent application Ser. No.09/729,611, filed on Dec. 4, 2000 which is a continuation of U.S. patentapplication Ser. No. 09/100,295 filed Jun. 19, 1998, now U.S. Pat. No.6,157,442.

BACKGROUND OF THE INVENTION

This invention relates generally to a sensor device and moreparticularly to a micro optical sensor device which may be employed in avariety of sensor applications to monitor, sense, or measure aconcentration of a material within a sample.

There are numerous applications in which a device is used to monitor ordetect a concentration of material within a substance. For example, itmay be required to know the concentration of a chemical in a sample ofmaterial such as knowing the concentration of sodium, calcium, or someother chemical composition in a sample. Monitoring or detecting aconcentration of a substance typically requires a set up of relativelycomplex, sensitive, and expensive equipment or instrumentation.Sometimes space requirements make it difficult to use the set up ofcomplex equipment and it would be advantageous to have equipment whichhas small dimensions and is easily transportable. Additionally, suchcomplex equipment may not provide results which are of a highresolution.

One known and important application for monitoring a concentration of amaterial within a sample deals with checking blood glucose fordiabetics. There are at least two known techniques for monitoring bloodglucose levels in humans. The two techniques are invasive which involvesextracting samples with the use of needles or syringes and noninvasive.Typically, for the invasive method, a patient employs a small lancetdevice which is used to prick or puncture a finger. Blood is thencollected onto a strip which has incorporated therein a chemicalreagent. The strip is then placed inside of a device that opticallyreads the chemical reaction of the blood on the strip and converts thisto a blood glucose level. It has been found very important to controlglucose levels in diabetics to reduce any complications associated withdiabetes. Many samples or finger pricks may be required to be taken foranalysis during the course of a day. Self monitoring of blood glucose bya patient is therefore very important in the treatment of diabetes.Since finger pricking or lancing is required for self monitoring levelsof glucose in a patient, many patients avoid this because it is painfuland inconvenient. Therefore, a less invasive procedure would bedesirable. The other methods, which have been termed noninvasive,typically involve a device which uses near infrared light to detectblood glucose levels. These devices measure a glucose concentration inblood or an organism's tissue by use of an optical device without theneed to collect blood or fracturing a part of the organism's tissue.Although these devices use noninvasive methods, in that no blood iscollected, none of these devices have been commercially accepted orviable.

The present invention is designed to obviate and overcome many of thedisadvantages and shortcomings associated with the prior use of complextesting and monitoring equipment. Additionally, the present invention issimple to use, provides extremely quick results and high resolution, andis easily transportable. The present invention uses relativelyinexpensive components which result in a commercially viable product.Further, the micro optical fiber sensor device of the present inventionis relatively noninvasive since it does not require the drawing of bloodand provides immediate results which does not require related bloodprocessing such as centrifugation, storage, transportation, and othertime consuming testing.

SUMMARY OF THE INVENTION

The present invention is a sensor device for measuring a concentrationof a substance within a sample which comprises a sensor comprising anoptical transmission member having a first end and a second end, thesecond end having a tip portion attached thereto and an active materialincorporated within the tip portion, the tip portion adapted to beinserted into a sample, the active material capable of interacting witha substance within a sample, a light source coupled to the first end ofthe sensor for emitting a beam of light into and through the sensor andinto a sample, the emitted beam of light having a wavelength and theactive material interacting with a substance within a sample to changethe wavelength of the emitted beam of light to produce a reflected beamof light and the sensor for transmitting the reflected beam of light outof the second end thereof, means for receiving the reflected beam oflight from the second end of the sensor for producing a signalindicative of the reflected beam of light, and a processor for receivingthe signal indicative of the reflected beam of light and for processingthe signal to determine the concentration of a substance within asample.

Another example of the present invention is a sensor device formeasuring a concentration of a substance within a sample which comprisesa sensor comprising an optical transmission member having a first endand a second end, the second end having a tip portion attached theretoand an active material incorporated within the tip portion, the tipportion adapted to be inserted into a sample, the active materialcapable of interacting with a substance within a sample, a light sourcefor emitting a beam of light of a preselected wavelength with the lightsource being coupled to an optical device capable of transmitting thebeam of light Therethrough, the transmitted beam of light being directedinto the first end of the sensor, through the sensor and out of thesecond end into a sample, the active material interacting with asubstance within a sample to change the wavelength of the transmittedbeam of light to produce a reflected beam of light and the sensor fortransmitting the reflected beam of light from the second end, throughthe sensor, and out of the first end thereof, the optical device beingfurther capable of reflecting the reflected beam of light, means forreceiving the reflected beam of light which is reflected by the opticaldevice for producing a signal indicative of the reflected beam of light;and a processor for receiving the signal indicative of the reflectedbeam of light and for processing the signal to determine theconcentration of a substance within a sample.

A further example of the present invention is a sensor device formeasuring a concentration of a substance within a sample which comprisesa sensor comprising an optical transmission member having a first endand a second end, the second end having a tip portion attached theretoand a first and a second active material incorporated within the tipportion, the tip portion adapted to be inserted into a sample, the firstactive material capable of interacting with a first substance within asample and the second active material capable of interacting with asecond substance within a sample, a light source coupled to the firstend of the sensor for emitting a beam of light into and through thesensor and into a sample, the emitted beam of light having a wavelengthand the first active material interacting with a first substance withina sample to change the wavelength of the emitted beam of light toproduce a first reflected beam of light, the second active materialinteracting with a second substance within a sample to change thewavelength of the emitted beam of light to produce a second reflectedbeam of light, and the sensor for transmitting the first and secondreflected beams of light out of the second end thereof, means forreceiving the first and second reflected beams of light from the secondend of the sensor for producing a first signal indicative of the firstreflected beam of light and a second signal indicative of the secondreflected beam of light, and a processor for receiving the first andsecond signals and for processing the first and second signals todetermine the concentration of a first substance within a sample and theconcentration of a second substance with a sample.

In light of the foregoing comments, it will be recognized that aprincipal object of the present invention is to provide an improvedsensor device which is hand held, portable, and easy to operate.

Another object of the present invention is to provide a sensor devicewhich has a tip portion of an extremely small size so that when it isinserted into a hand of a patient little or no sensation will beproduced or detected.

A further object of the present invention is to provide a sensor devicewhich is of simple construction and design and which can be easilyemployed with highly reliable results.

Another object of the present invention is to provide a sensor devicewhich is accurate and provides readings in a short time span.

A still further object of the present invention is to provide a sensordevice which is compact in design and is easily transportable forpersonal use.

These and other objects and advantages of the present invention willbecome apparent after considering the following detailed specificationin conjunction with the accompanying drawings,

wherein:

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a micro optical sensor deviceconstructed according to the present invention;

FIG. 2 is a block diagram of the micro optical sensor device constructedaccording to the present invention;

FIG. 3 is a perspective view of a tip portion of the micro opticalsensor device shown in FIG. 1;

FIG. 4 is a schematic view of the micro optical sensor device of thepresent invention being employed to sense a concentration in a sample;

FIG. 5 is a block diagram of a second embodiment of the micro opticalsensor device constructed according to the present invention;

FIG. 6 is perspective view of the sensor device of FIG. 5 illustratedmonitoring a concentration of glucose in a hand of a patient; and

FIG. 7 is a block diagram of a third embodiment of the micro opticalsensor device constructed according to the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring now to the drawings, wherein like numbers refer to like items,number 10 identifies a preferred embodiment of a micro optical sensordevice constructed according to the present invention. As illustrated inFIG. 1, the device 10 comprises a pencil or pen shaped body 12 whichincludes a tip portion 14, a central body portion 16, and an end cap 18.The central body portion 16 further includes a display device 20, suchas an LED (light emitting diode) type display or an LCD type display,for displaying information. The end cap 18, which may be removable fromthe central body portion 16, is used to allow access into the interiorof the central body portion 16. Batteries (not shown) can be insertedinto the central body portion 16 to supply power to the device 10, aswill be explained. The central body portion 16 may also include anON/OFF switch 22 which may be used to operate the device 10. Otherswitches (not shown) may be incorporated into the central body portion16 to further control the device 10. Additionally, the central bodyportion 16 houses electronic circuitry and other components which willbe illustrated and explained in further detail herein. The device 10 issized and shaped to be a hand held type device which is portable andpreferably is the size and shape of a pencil or a pen.

With reference now to FIG. 2, a block diagram of the circuitry andcomponents of the device 10 is shown. The device 10 includes a lightsource 30 which may be an LED, a laser, a laser diode, or otherexcitation source. The light source 30 is adapted to project a beam oflight 32 into an optical transmission member 34. The opticaltransmission member 34 transmits a beam of light 36 to a tip device 38which is part of the tip portion 14.

The optical transmission member 34 and the tip device 38 can be anydevice capable of transmitting light. For example, a portion of fiberoptic is used in the preferred embodiment. Various types of organicpolymers such as polystyrene, PMMA, polycarbonate, SAN,polyacrylonitrile and SU-8 epoxy resins can also be used. The opticaltransmission member can also be an inorganic alkoxysilane or a form ofglass such as lead borosilicate or fused silica. The opticaltransmission member can be any combination of these light transmittingmaterials.

The beam of light 36 passes through the tip device 38 and a reflectedbeam of light 40 can be reflected back from a sample (not shown) throughthe tip device 38 to a detector 42. The reflected beam of light 40typically has a wavelength or a frequency which is different than thewavelength or frequency of the beam of light 36. The detector 42 is inturn connected to a computer 44 via an electrical connection such as awire 46. The detector 42 provides electrical signals over the wire 46 tothe computer 44. The computer 44 may consists of, by way of examples, amicroprocessor, a microcontroller, an ASIC chip, or any other knownequivalent device which is capable of processing electrical signals. Thecomputer 44 is further operatively connected to a power supply 48, suchas batteries, by a wire 50. The computer 44 may also connected to thedisplay device 20, the switch 22, and the light source 30 although suchconnection is not illustrated in FIG. 2. Additionally, the computer 44may also be connected to other switches (not shown) which may beprovided with the device 10. In this manner, the additional switches areused to further control or operate other functions of the device 10.

The tip device 38 is shown in greater detail in FIG. 3 and is preferablya small device on the order of microns in diameter. The tip device 38may be constructed as is disclosed in U.S. Pat. Nos. 5,361,314 and5,627,922. For example, the tip device can be prepared by severalprocesses such as heat pulling, acid and/or solvent etching, lasermicro-machining, laser post processing, E-beam micro-machining,injection molding, corona or electrical arcing, ultra-soundmodification, high impact/high temperature powder crushing, grinding,masked lithography/etching, and micro-stereo lithography. In particular,in the preferred embodiment the tip device 38 includes a non-taperedportion 60 and a tapered portion 62 which is coated with an opaquematerial 64. Other shapes and configurations can also be used. The tipdevice 38 further includes a first end 66 and a second end 68. Thesecond end 68 further has a tip or portion 70 of material which isadhered thereto. The tip 70 is chemically treated which enables the tip70 to interact with the sample to be detected. Properties of the sensoror tip device 38 may vary dependent upon the sample and the chemical orsubstance to be detected by the device 10. As constructed, the tipdevice 38 allows for the beam of light 36 to pass through the first end66, the second end 68, and the tip portion 70 and the reflected beam 40is allowed to pass through the tip portion 70, the second end 68, andthe first end 66.

As indicated above, the tip device 38 is extremely small on the order ofone-thousandth the width of a human hair and because of this size it canbe inserted through gaps in most cells or through the membrane of a cellwithout damaging the cell. The tip 70 may be bathed in chemical coatingsselected to react with biological compounds such as acid, calcium,oxygen, glucose, potassium, sodium, or any other material to bedetected. The beam of light 36 which is transmitted through the tipdevice 38 glows with its brightness and color varying according to theconcentration of the target chemical. The portion 70 is a photochemicalsensor which is less than ten microns in diameter. Again, the portion 70is small enough that it can pass through the membrane of a cell tomonitor the concentration and nature of chemicals within the cell.

The tip device 38 may have specific chemical sensitivities based uponthe properties of a dye matrix. A dye may be chemically activated by adifferent chemical compound which enables sensing of a specific chemicalproperty within a sample or a substance. The tip device. 38 provides forenhanced sensitivity, selectivity, and stability when detecting aconcentration within a sample or substance. The tip portion or device 38may comprise a biologically active compound that is immobilized in anenvironment that is optically reactive. Additionally, the biologicallyactive compound can, in itself, be optically active. The sensor device10 interacts with the substance or sample to detect a specific chemicalor concentration within the substance.

With reference now to FIGS. 1, 2, and 4, the operation of the device 10will be explained in detail. In order to operate the device 10, theon/off switch 22 is pressed to initialize the device 10. Once powered,the device 10 may be inserted into a sample 80 to test for a particularconcentration of material within the sample 80. As shown in FIG. 4, thesample to be tested is a liquid 82 in a beaker 84. The tip portion 70 isinserted into the liquid 82 and at this point in time a beam of light,such as the beam of light 36, is transmitted into the liquid 82. Withthe tip portion 70 being in contact with the liquid 82, the liquid 82reacts chemically with the tip portion 70 and the color of the chemicalcomposing the sensor device 10 changes. As a result of this change, thecolor of the light reflected back into the tip portion 70 changes, suchas reflected beam of light 40, as compared to the beam of light 36. Theamount of this change can be quantified by the detector 42. Oncequantified signals are provided to the computer 44 which performs acalculation to determine the concentration of the particular chemicalbeing sensed and the result may be displayed in the display 20.

In further detail and again with reference to FIGS. 1, 2, and 4, oncethe device 10 is actuated by pressing the switch 22, the beam of light32 is sent from the light source 30 through the opticaltransmission-member 34 which transmits the beam of light 36 through thetip device 38 into the liquid 82. The reflected beam of light 40 isreflected from the liquid 82 into the tip device 38 to the detector 42.The detector 42 provides signals to the computer 44 and the computer 44determines the concentration of a particular chemical within the liquid82. This process may be termed photochemical optical fiber sensing.Additionally, the chemical properties of the tip portion 70 of thesensor portion 14 may be changed to react with another chemical todetect some other chemical within a sample. Further, instead of changingthe chemical properties of the tip portion 70, it may only be necessaryto change the light source 30 to detect some other chemical within asample.

FIG. 5 illustrates another preferred embodiment of a sensor device 100which comprises a computer 102 which is connected to a light source 104by a wire 106. The light source 104 operates to provide light,represented by a light beam 108, to be projected at an optical device110. The optical device 110 may be a mirror which allows light, which isrepresented by a light beam 112, of a particular or predeterminedwavelength or frequency to pass through the device 110 to be directed atan optical transmission member 114. The optical transmission member 114is connected to a connector device 116 and the optical transmissionmember 114 passes light, such as light beam 118, through to theconnector device 116. A beam of light 120 is transmitted from theconnector device 116 to a sensor device 122. The sensor device 122 issimilar to the tip portion or device 38 which was shown in FIGS. 2 and3. Light, such as light beam 124, which may be reflected back from asample (not shown) and through the sensor device 122, is directed to theconnector device 116. A light beam 126 is transmitted from the connectordevice 116 to the optical transmission member 114. The opticaltransmission member 114 in turn directs a light beam 128 to the opticaldevice 110. The optical device 110 provides a light beam 130 of aparticular or predetermined wavelength or frequency to be directed at anoptical detector device 132. The optical detector 132 is connected by awire 134 to the computer 102 and provides signals to the computer 102.The computer 102 is operatively programmed to use the signals providedfrom the optical detector 132 to calculate or determine theconcentration of a substance within a sample.

Referring now to FIG. 6, the sensor device 100 is further showncomprising a pencil like body 150 which includes a central body portion152, an end cap 154, and a tip portion 156. The central body portion 152has a display 158 for displaying information such as glucoseconcentration. An ON/OFF switch 160 is also included in the central bodyportion 152 for controlling operation of the sensor device 100. Thesensor device 100 is illustrated having the tip portion 156 insertedinto a hand 162 of a patient. As has been previously discussed, the tipportion 156 is of an extremely small size and because of its small sizeinsertion of the tip portion 156 into the hand 162 will produce littleor no sensation. The other components of the sensor device 100, whichwere discussed with reference to FIG. 5, are all housed within thecentral body portion 152.

With particular reference now to FIGS. 5 and 6, in operation, the tipportion 156 of the sensor device 100 is inserted into a sample, such asthe hand 162, to detect the presence of a concentration of material,such as for example glucose. Once inserted into the hand 162, the ON/OFFswitch 160 is pressed by the user to initiate operation of the sensordevice 100. Actuation of the sensor device 100 causes the computer 102to operate the light source 104. The light beam 108 is sent to theoptical device 110 which causes the light beam 112 to be directed at theoptical transmission member 114 which in turn produces the light beam118. The light beam 118 passes into the connector 116 and emerges as thelight beam 120 which is provided to the sensor device 122. With thesensor device 122 being in contact with the hand 162, the sensor device122 reacts chemically with the hand 162 and the color of the chemicalcomposing the sensor device 122 changes. The color of the light beam 124which is reflected back into the sensor device 122 is then directed backinto the connector 116. The beam of light 126 is transmitted from theconnector 116 to the optical transmission member 114 which in turntransmits the beam of light 128 to the optical device 110. The opticaldevice allows the light beam 130 to be directed to the optical detector134. The optical detector 134 provides signals to the computer 102 whichthen determines the concentration of glucose within the hand 162. Theresult may then be displayed in the display 158 of the sensor device100. Once the result is displayed, the user may remove the sensor device100 from the hand 162 and press the ON/OFF switch 160 to turn the sensordevice 100 off. The sensor device 100 may be used again to determine theglucose concentration.

The sensor device 100 in actual construction is a small device and sizedand shaped to be pencil like. Because of its small size the sensordevice 100 may be used as a portable monitoring device. Additionally,the computer 102 may be a microprocessor chip, a customized integratedcircuit chip such as an ASIC chip, or any other device which is capableof processing electrical signals. Although not shown or made referenceto, a rechargeable battery or a replaceable battery may be used to powerthe sensor device 100. Further both devices 10 and 100 may haveincorporated therein a memory for storing information such as, forexample, a log of monitoring of the patient's glucose concentration,time of day of monitoring, and date of monitoring.

FIG. 7 depicts a block diagram of a third embodiment of a micro opticalsensor device 200. The sensor device 200 comprises a computer 202 whichis connected to a light source 204 via a wire 206. The light source 204projects a beam of light 208 into a section or portion of a opticaltransmission member 210. The optical transmission member 210 isconnected to a tip portion or device 212 and passes a beam of light 214to the tip device 212. The tip portion or device 212 is similar inseveral respects to the tip device 38 which was illustrated in FIGS. 2and 3, however, the tip device 212 is different in one respect. Infabricating the tip device 212, as discussed in U.S. Pat. Nos. 5,361,314and 5,627,922, the tip device 212 uses a multi-dye matrix tip which isphotochemically attached to the tip device 212 to form amulti-functional sensor having an extremely small size. The multi-dyeconfiguration allows for a multi-function sensor in which each dye maybe chemically activated by a different chemical compound. This enablesthe tip device 212 to sense, detect, or monitor more than one chemical.

Since the tip device 212 is capable of monitoring two differentchemicals, two different light beams, such as light beams 216 and 218,will be reflected back from a sample and through the tip device 212.Each of the light beams 216 and 218 are directed to a detector 220 and222, respectively. Although not shown, it is possible to have an opticalcomponent, such as band pass filters, placed between the tip device 212and the detectors 220 and 222 to direct the light beams 216 and 218 to aspecific detector 220 or 222. The detector 220 is connected to thecomputer 202 by a wire 224 and electrical signals indicative of theconcentration of a particular chemical within a sample is provided tothe computer 202. Additionally, the detector 222 is connected to thecomputer 202 by another wire 226 and signals indicative of anotherchemical within the sample are provided to the computer 202. In thismanner, the computer 202 is programmed to receive the signals from thedetectors 220 and 222 and calculate or determine the concentrations ofthe two chemicals within the sample. Additionally, the sensor device 200may include a display (not shown) which would display the results of thecalculations. The sensor device 200 may also be provided with a powersupply 228 which is operatively connected by a wire 230 to the computer202. Although the device 200 is depicted to show the monitoring of atleast two different chemical compounds it is also contemplated that morethan two chemical compounds may be sensed, detected, or monitored by thedevice 200 by adding additional components, as has been taught andillustrated.

From all that has been said, it will be clear that there has thus beenshown and described herein a micro optical sensor device which fulfillsthe various objects and advantages sought therefor. It will be apparentto those skilled in the art, however, that many changes, modifications,variations, and other uses and applications of the subject micro opticalsensor device are possible and contemplated. All changes, modifications,variations, and other uses and applications which do not depart from thespirit and scope of the invention are deemed to be covered by theinvention, which is limited only by the claims which follow.

1. A method of using a sensor device for measuring a concentration of asubstance within a sample comprising the steps of: inserting a tipportion of a sensor into a sample, the sensor comprising an opticaltransmission member having a first end and a second end, the second endhaving the tip portion attached thereto and an active materialincorporated within the tip portion, the active material capable ofinteracting with a substance within the sample; emitting a beam of lightinto the first end of the sensor, through the optical transmissionmember and the tip portion and into the sample, the beam of light havinga first wavelength; producing a reflected beam of light from theinteraction of the active material with the substance within the sample,the reflected beam of light having a second wavelength different fromthe first wavelength; receiving the reflected beam of light andproducing a signal indicative of the reflected beam of light; anddetermining the concentration of the substance within the sample basedon the produced signal.
 2. The method of claim 1, further comprising thestep of preselecting the active material to interact with the substancewithin the sample.
 3. The method of claim 1, wherein the opticaltransmission member comprises a material selected from the groupconsisting of a fiber optic, organic polymers, inorganic alkoxysilanes,lead borosilicate, fused silica, and combinations thereof.
 4. The methodof claim 1, wherein the substance to be measure is glucose.
 5. Themethod of claim 1, wherein the sample is a human.
 6. The method of claim1, further comprising the step of forming the sensor with a pencilshaped and sized body having a tip portion, a central body, and an endcap.
 7. The method of claim 1, further comprising the step of formingthe tip portion to comprise a biologically active compound that isimmobilized in an environment that is optically reactive.
 8. The methodof claim 1, further comprising the step of forming the tip portion to beshaped and adapted to be inserted into a cell without damaging the cell.9. The method of claim 8, wherein the forming step comprises forming thetip portion to have a diameter less than 30 microns.
 10. The method ofclaim 9, wherein the diameter is less than 20 microns.
 11. The method ofclaim 10, wherein the diameter is less than 10 microns.
 12. A method ofusing a sensor device for measuring a concentration of a substancewithin a sample comprising the steps of: inserting a tip portion of asensor into a sample, the sensor comprising an optical transmissionmember having a first end and a second end, the second end having thetip portion attached thereto and a first active material and a secondactive material incorporated within the tip portion, the first activematerial capable of interacting with a first substance within thesample, the second active material capable of interacting with a secondsubstance within the sample; emitting a beam of light into the first endof the sensor, through the optical transmission member and the tipportion and into the sample, the beam of light having a firstwavelength; reflecting a first reflected beam of light off of the firstactive material, the first reflected beam of light having a secondwavelength different from the first wavelength of the emitted beam oflight, the first reflected beam of light relating to a concentration ofthe first substance within the sample; reflecting a second reflectedbeam of light off of the second active material, the second reflectedbeam of light having a third wavelength different from the firstwavelength of the emitted beam of light and the second wavelength of thefirst reflected beam of light, the second reflected beam of lightrelating to a concentration of the second substance within the sample;detecting the first and second reflected beams of light; and determininga concentration of the first substance within the sample from the firstdetected reflected beam of light, and a concentration of the secondsubstance within the sample from the second detected reflected beam oflight.